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FDA EstablishmentFDA Device Establishment Registration & Listing
U.S. Food & Drug Administration (openFDA) · Tier-1 · research-only (never on individual profiles)
The FDA device establishment registration and listing feed publishes the firms registered to manufacture or distribute medical devices — registration number, FEI number, firm name, establishment type, and location. Fonteum keys each row on registration number.
How this source shows up on Fonteum.
Aggregate device-firm reference, keyed to the registered establishment (name-normalized for a deferred Open Payments cross-link). Fonteum surfaces the establishment identity and type; the entity-graph link is held for ambiguous matches, never written.
What this source does NOT mean
An establishment registration is an administrative FDA record that a firm registered a device facility — it is not a statement about any healthcare provider, not a quality measurement, and not a Fonteum assessment. A named firm is not an asserted provider-identity match.
Research and data questions this source supports.
- Enumerate the medical-device firms registered to manufacture or distribute devices, by establishment type and location.
- Build a device supply-chain map keyed to the registered establishment and FEI number.
- Cross-reference a device firm's registration against its recall enforcement history.
- Power a research surface on device-establishment density by state and country.
Dataset size: 24,809 registered establishments (2026-06-14 snapshot)
Per-field display contract.
Fields listed below show their configured `display_allowed` flag from the §94 provenance schema. Fields marked write-locked are captured for audit and are not rendered on profile pages.
Research-only — never on profiles
6 fieldsWhat we can’t infer from this source.
- Tier-1 — aggregate research context only; never rendered on individual provider profiles.
- Firm-keyed by registration number; firm name is name-keyed, with the entity-graph cross-link deferred.
- Registration is a facility-administration record; it is not a measure of device quality or safety.
- openFDA omits empty fields; some registrations carry sparse type or expiry detail.
Authority, license, publisher cadence.
Authority
U.S. Food & Drug Administration (openFDA)
Tier
Tier-1 · research-only (never on individual profiles)
Publisher / configured cadence
Declared or configured cadence: Weekly — openFDA republishes the device registration partition. Not evidence of the latest loaded source date.
License
openFDA — CC0 public domain (U.S.-government works). Free to use; no API key required for bulk downloads. License ↗
Official URL
Attribution requirement
Source: U.S. Food & Drug Administration (openFDA) — Device Establishment Registration · Snapshot {YYYY-MM-DD}
What the source allows.
openFDA data is CC0 public domain. No API key is required for bulk downloads; attribution to openFDA is the courtesy ask. Snapshot and attestation fields must be read from the specific artifact; no provenance fact currently links deterministically to a signature.
What a single field looks like in the graph.
This worked example shows the provenance shape used when a surfaced field has populated source, last-checked, display-rule, and confidence metadata. Individual fields may omit unavailable values.
Field
Device establishment (research-only)
Sample value
Reg 0000000 · Example Device Firm · Manufacturer · CA US
Provenance line
Source: openFDA Device Registration · Snapshot 2026-06-14 · Methodology fda-establishment/v1 · Display rule: firm-keyed research reference
Official API, bulk download, and Fonteum endpoints.
Official API / download
Fonteum surface
Common questions about FDA Establishment.
- What is the FDA device establishment registration dataset?
- It is the openFDA feed of firms registered to manufacture or distribute medical devices — registration number, FEI number, firm name, establishment type, and location. Registration is required under FDA's device regulations; the feed is the public listing of registered establishments.
- Does registration mean a device is safe or approved?
- No. Establishment registration is an administrative record that a firm registered a device facility. It is not a clearance, an approval, or a measure of device quality or safety — those are separate FDA processes.
- Where can I download this data?
- From the openFDA device registration/listing API (api.fda.gov/device/registrationlisting.json) and bulk downloads at open.fda.gov. openFDA data is CC0 public domain — free to use and redistribute with attribution, no API key required.
- Is a registered establishment linked to a provider?
- No. Establishments are firm-keyed by registration number; the firm name is recorded by name. There is no NPI, and the Open Payments cross-link is deferred — ambiguous matches are held, not written.
- How fresh is the data?
- openFDA republishes the device registration partition roughly weekly; Loaded dates must be read from the specific response; publisher cadence is not proof of a completed load. As of the 2026-06-14 snapshot, Fonteum holds 24,809 registered establishments.
Where this source already shows up.
Related sources in the graph
- /sources → The generated source-catalog subset — documented datasets Fonteum cites.
- /data-provenance → The provider graph — pipeline diagram, source-family clusters, field-level provenance examples, display rules.
- /methodology → Documented sourcing, publisher cadence, observed freshness, and corrections policy.
- /editorial-policy → Independence, sourcing, conflicts, corrections, retractions.